FIELD SAMPLING AND MEASUREMENT ORGANIZATION SECTOR VOLUME 2

Transcription

1 FSMO-V FIELD SAMPLING AND MEASUREMENT ORGANIZATION SECTOR VOLUME 2 GENERAL REQUIREMENTS FOR ACCREDITATION BODIES ACCREDITING FIELD SAMPLING AND MEASUREMENT ORGANIZATIONS TNI StandardTNI Voting Draft Standard Adopted May 1, 2007November 15 th, 2012 Form P.O. Box 2439 Weatherford, TX The NELAC Institute Some material in this document is reproduced from ISO/IEC 17011:2004 with permission of the American National Standards Institute (ANSI) on behalf of the International Organization for Standardization (ISO). No part of the reproduced language may be copied or reproduced an any form, including an electronic retrieval system or be made available on the internet, a public network, by satellite or otherwise without prior written permission of ANSI, 25 West 43 rd Street, New York, NY

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3 May 1, 2007 page i PREFACE This Standard is the result of many hours of effort by those volunteers on The NELAC Institute (TNI) Field Activities Committee. The TNI Board of Directors wishes to thank these committee members for their efforts in preparing this Standard as well as those TNI members who offered comments during the voting process. It is conformant with the requirements of ISO/IEC 17025:2005(E). This publicly available TNI document does not contain the ISO/IEC copyright protected language, but does reference applicable ISO clauses. In these situations, it is useful to read the TNI Standard along with the ISO/IEC standard. Wherever an ISO clause is referenced (in italics), the language from that clause is applicable.. Any additional TNI language then follows, in plain text, as a NOTE or as an additional numbered standard item. TNI has an agreement with ASTM International and the American National Standards Institute (ANSI) to provide, to TNI members at a discounted rate, a version of this Standard with the ISO/IEC language included; contact Jerry Parr at TNI for more information. This Standard may be used by any organization that wishes to implement a program for the accreditation of organizations performing sampling or field measurements. Standard Revision History Action Date Final Standard Published May 1, 2007 Revision to include changes accepted in 2007 (voted in) but not included in document. Revision 1.0 published as a Working Draft Standard Revision 1.0 published as a Voting Draft Standard Revision 1.0 published as a modified Voting Draft Standard November 30, 2010 July 6, 2012 November 15 th, 2012 June 5 th, 2013 Form Form

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5 May 1, 2007 page iii VOLUME 2 GENERAL REQUIREMENTS FOR ACCREDITATION BODIES ACCREDITING FIELD SAMPLING AND MEASUREMENT ORGANIZATIONS Table of Contents 1.0 INTRODUCTION, SCOPE AND APPLICABILITY Scope NORMATIVE REFERENCES TERMS AND DEFINITIONS Accreditation Accreditation Body Accreditation Body Logo Accreditation Certificate Accreditation Symbol Appeal Assessment Assessor Complaint Conformity Assessment Body Consultancy Expert Extending Accreditation Interested Parties Lead Assessor Reducing Accreditation Scope of Accreditation Surveillance Suspending Accreditation Withdrawing Accreditation Witnessing Field Field Measurement Field Sampling Finding FSMO Matrix Preservation Proficiency Testing SamplingProficiency Testing Provider Proficiency Testing Provider Accreditor Sampling Measurement ACCREDITATION BODY Legal Responsibility Structure Impartiality Confidentiality Liability and Financing Accreditation Activity MANAGEMENT General... 95

6 May 1, 2007 page iv VOLUME 2 GENERAL REQUIREMENTS FOR ACCREDITATION BODIES ACCREDITING FIELD SAMPLING AND MEASUREMENT ORGANIZATIONS Table of Contents cont. 5.2 Management System Document Control Records Nonconformities and Corrective Actions Preventive Actions Internal Audits Management Reviews Complaints HUMAN RESOURCES Personnel Associated with the Accreditation Body Personnel Involved in the Accreditation Process Monitoring Personnel Records ACCREDITATION PROCESS Accreditation Criteria and Information Application for Accreditation Resources Review Subcontracting the Assessment Preparation for Assessment Document and Record Review On-Site Assessment Analysis of Findings and Assessment Report Decision-Making and Granting Accreditation Appeals Reassessment and Surveillance Extending Accreditation Suspending, Withdrawing or Reducing Accreditation Records on CABs (FSMOs) Proficiency Testing and Other Comparisons for Laboratories RESPONSIBILITIES OF THE ACCREDITATION BODY AND THE CAB Obligations of the CAB Obligations of the Accreditation Body Reference to Accreditation and Use of Symbols

7 May 1, 2007 page 1 VOLUME 2 GENERAL REQUIREMENTS FOR ACCREDITATION BODIES ACCREDITING FIELD SAMPLING AND MEASUREMENT ORGANIZATIONS 1.0 INTRODUCTION, SCOPE AND APPLICABILITY This TNI Standard includes requirements applicable to Accreditation Bodies (AB) engaged in accrediting field sampling and measurement organizations (FSMO). This Standard is intended as an application of ISO/IEC (E) Conformity Assessment - General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies. The ISO/IEC clauses are provided in italics, with the additional TNI clauses in normal font. Unless the contrary is clearly indicated, all references to singular nouns include the plural noun, and all references to plural nouns include the singular. Some clauses in this Standard contain notes. The notes are used to explain a particular requirement or to provide clarifying examples. The notes do not supersede or modify requirements of the Standard and do not convey any additional requirements. 1.1 SCOPE (ISO/IEC 17011:2004(E), Clause 1) NOTE 2: The term FSMO under this TNI Standard corresponds to Conformity Assessment Bodies under ISO/IEC The term Accreditation Bodies under this TNI Standard corresponds to Accreditation Bodies under ISO/IEC NOTE 3: This Standard specifies the essential requirements and processes that relate to an accreditation body and to a FSMO in the granting of, and application for, accreditation, respectively for environmentally-related field sampling and measurements. 2.0 NORMATIVE REFERENCES (ISO/IEC 17011:2004(E), Clause 2) 3.0 TERMS AND DEFINITIONS 3.1 Accreditation (ISO/IEC 17011:2004(E), Clause 3.1) 3.2 Accreditation Body (ISO/IEC 17011:2004(E), Clause 3.2) 3.3 Accreditation Body Logo (ISO/IEC 17011:2004(E), Clause 3.3) 3.4 Accreditation Certificate (ISO/IEC 17011:2004(E), Clause 3.4) 3.5 Accreditation Symbol (ISO/IEC 17011:2004(E), Clause 3.5) 3.6 Appeal (ISO/IEC 17011:2004(E), Clause 3.6) 3.7 Assessment (ISO/IEC 17011:2004 (E), Clause 3.7) 3.8 Assessor (ISO/IEC 17011:2004(E), Clause 3.8) Form Form Form Form

8 May 1, 2007 page Complaint (ISO/IEC 17011:2004 (E), Clause 3.9): 3.10 Conformity Assessment Body (CAB) (ISO/IEC 17011:2004(E), Clause 3.10) NOTE 2: This TNI Standard is concerned with conformity assessment bodies commonly known as field sampling and measurement organizations Consultancy (ISO/IEC 17011:2004(E), Clause 3.11) NOTE: Consultancy refers to the position or practice of a qualified person paid for advice and services and does not include information and assistance provided by government agencies Expert (ISO/IEC 17011:2004(E), Clause 3.12) 3.13 Extending Accreditation (ISO/IEC 17011:2004(E), Clause 3.13) 3.14 Interested Parties (ISO/IEC 17011:2004(E), Clause 3.14) 3.15 Lead Assessor (ISO/IEC 17011:2004(E), Clause 3.15) 3.16 Reducing Accreditation (ISO/IEC 17011:2004(E), Clause 3.16) 3.17 Scope of Accreditation (ISO/IEC 17011:2004(E), Clause 3.17) 3.18 Surveillance (ISO/IEC 17011:2004(E), Clause 3.18) 3.19 Suspending Accreditation (ISO/IEC 17011:2004(E), Clause 3.19) 3.20 Withdrawing Accreditation (ISO/IEC 17011:2004(E), Clause 3.20) 3.21 Witnessing (ISO/IEC 17011:2004(E), Clause 3.21): Additional Terms and Definitions NOTE: The relevant definitions listed in the referenced ISO documents apply when using this document. Definitions related to this document, which are used differently or do not exist in the ISO references are defined below Field: Any location where work is performed outside the controlled environment of a laboratorylegal entity s facility (e.g. laboratory) Field Measurement: The quantitative determination of physical, chemical, biological or radiological properties of a matrix by measurements made in the field Field Sampling: The process of obtaining a representative portion of an environmental matrix suitable for laboratory or field measurement or analysis Finding: An assessment conclusion referenced to an accreditation standard and supported by objective evidence that identifies compliance with and/or a deviation from an accreditation standard requirement FSMO: Field Sampling and Measurement Organization, See Clause Matrix: The substance within which a measurement is made or from which a separate sample is collected. The matrix includes the physical, chemical, biological or radiological characteristics of the substance.

9 May 1, 2007 page Preservation: Physical or chemical treatment of a sample to prevent the gain or loss of target analytes before analysis; filtration, refrigeration and addition of chemical reagents are examples of preservation techniques Proficiency Testing (PT): A means of evaluating an organization s performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an external source.a Proficiency Testing Provider Proficiency Testing Provider (PTP): Any private party or government entity accredited by a TNI recognized PTPA that meets the stringent criteria to produce and distribute TNI samples, evaluate study results against published performance criteria, and report the results to FSMOs, ABs, and its PTPA Proficiency Testing Provider Accreditor (PTPA): An organization with technical expertise, administrative capacity and financial resources sufficient to implement and operate a program of PTP evaluation and oversight that meets the responsibilities and requirements established by the TNI FSMO and NELAC Standard Sampling: See (ISO/IEC 17025; 2005(E), Clause 5.7.1, NOTE 1) 3.33 Measurement: The process or result of determining, by comparison to a standard, the dimensions, quantity, capacity, or other characteristic of a measurand. 4.0 ACCREDITATION BODY 4.1 Legal Responsibility (ISO/IEC 17011:2004(E), Clause 4.1) An accreditation body shall seek recognition for its accreditation activities from an applicable Standards Setting Authority The NELAC Institute, that who shall use this Standard as the basis for granting recognition. 4.2 Structure NOTE 1: An accreditation body for an FSMO may be a government authority or non-government organization engaged in specifically assessing conformity to these Standardsthis Standard. NOTE 2: A governmental authority, having the authority, rights and responsibilities necessary to carry out an FSMO accreditation program, may be a territory, state, or federal entity. NOTE 3: A government authority may designate the appropriate agencies or departments as its recognized accreditation body for the accreditation for which recognition is being sought by the FSMO. NOTE 4: A government accreditation body may contract with a non-government organization to be its recognized agent for all or part of its accreditation activities for the accreditation for which recognition is being sought by a FSMO provided that the government authority retains final authority over the agent in all matters relating to FSMO accreditation activities as defined within this Standard and agreed contract terms ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause 4.2.4

10 May 1, 2007 page ISO/IEC 17011:2004(E), Clause NOTE: In the case of an accreditation body within a federal or state government department or entity, top management refers to the management of the organizational unit (and not the department or entity) having authority and responsibility for the accreditation program ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause NOTE: In the case of an accreditation body within a federal or state government department or entity, structure refers to the structure of the organizational unit (and not the department or entity) having authority and responsibility for the accreditation program. 4.3 Impartiality ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause The accreditation body, within the scope and applicability of its prevailing rules and regulationsof its policies and procedures and, for government ABs, its applicable rules and regulations, shall also establish one or more committees for assistance in interpretation of requirements and for advising the accreditation body on the granting of accreditation and on any technical matters relating to the operation of its accreditation program. NOTE 1: Members of advisory committees who may have a conflict of interest shall not have access to information about granting accreditation to a specific FSMO ISO/IEC 17011:2004(E), Clause The accreditation body shall have no rules, regulations, procedures or practices that: a) impose any financial conditions or restrictions for participation in the accreditation program other than any accreditation fees; or that b) conflicts with any territorial, state or federal laws governing discrimination ISO/IEC 17011:2004(E), Clause The accreditation body shall have a policy or arrangements to ensure that its management and technical staff are subject to the same conflict of interest disclosure requirements (designed to identify and eliminate potential conflict-of interest problems) as for the parent organization itself or for those government programs, units, divisions, bureaus etc., housing that house the accreditation body ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause 4.3.6

11 May 1, 2007 page ISO/IEC 17011:2004(E), Clause NOTE 3: The requirement that an accreditation body and its related bodies have a distinctive name, logo and or symbol may not be applicable or practical for government accreditation bodies For the instance of an Accreditation Body and FSMOs that are organizational units of the same department or agency of a government authority which is an accreditation body, or that have other organizational conflicts of interest, the AB shall: a) demonstrate by organizational structure, that the accreditation body s accreditation program manager and FSMO s technical director (however named) do not report within the same chain-of-command; and b) demonstrate by policies and procedures, that conflicts-of-interest do not exist; or c) direct the FSMO to apply for accreditation through any other recognized accreditation body. 4.4 Confidentiality (ISO/IEC 17011:2004(E), Clause 4.4) 4.5 Liability and Financing ISO/IEC 17011:2004(E), Clause NOTE 1: A government accreditation body shall have the same arrangements to cover liabilities and workman s compensation claims arising from its operations and activities as all other programs, units, divisions, bureaus, etc., in the department or agency in which the accreditation body is located. NOTE 2: A non-government accreditation body shall have appropriate coverage for liabilities and workman s compensation claims arising from its accreditation activities ISO/IEC 17011:2004(E), Clause Accreditation Activity (ISO/IEC 17011:2004(E), Clause 4.6) 5.0 MANAGEMENT 5.1 General (ISO/IEC 17011:2004(E), Clause 5.1) 5.2 Management System (ISO/IEC 17011:2004(E), Clause 5.2) ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause NOTE: The requirements within TNI Standard General Requirements for Field Sampling and Measurement Organizations, Volume 1, and ISO/IEC or ISO 9001 could serve as the basis for a quality manual ISO/IEC 17011:2004(E), Clause Quality Manual

12 May 1, 2007 page 6 The accreditation body shall have a quality manual appropriate to the type, range and volume of work performed as part of its accreditation activities and that addresses all requirements of this Standard. NOTE: The requirements within TNI Standard General Requirements for Field Sampling and Measurement Organizations, Volume 1, and ISO/IEC or ISO/IEC 9001 could serve as the basis for a quality manual. 5.3 Document Control (ISO/IEC 17011:2004(E), Clause 5.3) The accreditation body shall maintain in hard copy, electronic media or other means, a controlled document or documents describing its environmental FSMO accreditation program including: a) at a minimum, all information required of an FSMO to acquire and maintain accreditation through the accreditation body; and b) additional documentation requirements as described in Sections 4.6, 6.2 and of this Volume The accreditation body shall review such documents annually. a) A written record of this review shall be readily available. b) When the review of such document or documents reveals that the accreditation body s FSMO accreditation program has changed or is otherwise different from the accreditation program described in such documents, the document or documents shall be updated within thirty (30) calendar days of completion of the review. 5.4 Records (ISO/IEC 17011:2004(E), Clause 5.4) The accreditation body shall maintain in hard copy, electronic media or other means, a controlled document or documents describing its environmental FSMO accreditation program including: a) at a minimum, all information required of an FSMO to acquire and maintain accreditation through the accreditation body; and b) additional documentation requirements as described in Sections 4.6, 6.2 and of this Volume The accreditation body shall review such documents annually. a) A written record of this review shall be readily available for inspection upon request from the applicable registrar or other standards setting authority. b) When the review of such document or documents reveals that the accreditation body s FSMO accreditation program has changed or is otherwise different from the accreditation program described in such documents, the document or documents shall be updated within thirty (30) calendar days of completion of the review. 5.5 Nonconformities and Corrective Actions (ISO/IEC 17011:2004(E), Clause 5.5) 5.6 Preventive Actions (ISO/IEC 17011:2004(E), Clause 5.6) 5.7 Internal Audits ISO/IEC 17011:2004(E), Clause 5.7.1

13 May 1, 2007 page Internal audits shall include a review and effectiveness assessment of the accreditation body s quality manual When applicable, the accreditation body shall use the same policies and procedures for internal audits as used by all other programs, units, divisions, bureaus, etc., in the department or agency or organization in which the accreditation body is located ISO/IEC 17011:2004(E), Clause NOTE: The frequency of internal audits, normally at least once per year, should not be less than once every twenty-four (24) months if augmented (to demonstrate effective management systems) by alternate-year-audit by external agents ISO/IEC 17011:2004(E), Clause Management Reviews (ISO/IEC 17011:2004(E), Clause 5.8) m) Proficiency Testing Program 5.9 Complaints (ISO/IEC 17011:2004(E), Clause 5.9) 6.0 HUMAN RESOURCES 6.1 Personnel Associated with the Accreditation Body ISO/IEC 17011:2004(E), Clause The accreditation body shall have physical and human resources required for the operation of its accreditation program, necessary to complete action on an application within nine (9) months from the time a completed application is first received from the FSMO. This time period shall not apply if delays are caused by the FSMO responses to the accreditation process or, on-site assessment or proficiency testing requirements beyond the required time limits set forth in this Standard ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause NOTE: Rules defined by the accreditation body should include ethics policies and compliance requirements. See Clause , Note Personnel Involved in the Accreditation Process (ISO/IEC 17011:2004(E), Clause 6.2) Assessor s Roles and Responsibilities Accreditation program management In addition to the management system representative (see Clause 5), the accreditation body shall identify an individual or individuals responsible for day-to-day management of the accreditation program(s). This individual shall: a) be an employee of the accreditation body, and

14 May 1, 2007 page 8 b) have the technical expertise necessary to: i. plan and manage the matrix-specific FSMO accreditation program; i coordinate various facets of the FSMO accreditation program with territory, state, and federal or non-government accreditation bodies, as applicable; and provide input on the technical competence and performance of contractors or employees involved in the accreditation process Standards of professional conduct for assessors NOTE 1: Professional standards apply to every assessor, whether a government or nongovernment employee or an employee of a third party organization (agent), conducting assessments under an agreement with an accreditation body. NOTE 2: Assessors that knowingly engage in unprofessional activity may be liable for punitive actions as initiated by the assessor s accreditation body. NOTE 3: The Standards for Professional Conduct, as outlined in this Clause, are based upon US 5 CFR 2635, Standards of Ethical Conduct for Employees of the Executive Branch. a) Assessors shall: i. have no interest at play other than that of the accreditation body during the entire accreditation process; i iv. act impartially and not give preferential treatment to any organization or individual; provide equal treatment to all persons and organizations regardless of race, color, religion, sex, national origin, age, and/or disability; not use their position for private gain; nor solicit or accept any gift or other item of monetary value from any FSMO, FSMO representative, or any other affected individual or organization doing business with, or affected by, the actions of the assessor s employer or accreditation body; v. not hold financial interests that conflict with the conscientious performance of their duties; vi. v vi ix. not engage in financial transactions using information gained through their positions as assessors to further any private interest; not engage in employment activities (seeking or negotiating for employment) or attempt to arrange contractual agreements with a FSMO that would conflict with their duties and responsibilities as an assessor; not knowingly make unauthorized commitments or promises of any kind purporting to bind the affected accreditation body; and shall attempt to avoid any actions that could create even the appearance that they are violating any of the standards of professional conduct outlined in this clause. b) Assessors shall report to the accreditation body any personal issues or activities that constitute a conflict of interest before an assessment occurs.

15 May 1, 2007 page 9 i. If an unforeseen conflict becomes apparent during an assessment, the lead assessor shall consult, as soon as practicable, with the accreditation body to determine how to proceed with the assessment. i iv. The accreditation body shall determine if the reported issues and activities regarding a specific assessor constitute, or can be construed as, conflicts of interest. The accreditation body shall take action to ensure that the assessment can proceed without compromising its integrity and impartiality, or shall request that the assessment team terminate the assessment. The accreditation body shall have in place an independent appeals process in the event the FSMO and the accreditation body cannot achieve resolution on the conflict Basic On-Site Assessment Personnel Qualifications and Training Qualifications An assessor shall be qualified by the accreditation body prior to conducting an assessment. a) Each assessor shall complete or comply with the following: i. Sign a statement before conducting an assessment certifying that no conflict of interest exists; i iv. Provide any supporting information as required by the accreditation body. Failure to provide this information makes the proposed assessor ineligible to participate in the assessment program; and Be an experienced professional and hold at least a Bachelor s degree in a scientific discipline or have equivalent experience in environmental sampling and measurement. Be judged proficient by the accreditation body. b) Each assessor shall participate in at least four actual on-site assessments under the supervision of a qualified assessor (see following exception, item c). c) For a newly recognized accreditation body, assessors shall not be required to complete assessments under the supervision of a qualified assessor provided: i. they have completed at least four other FSMO on-site assessments; i they have been judged proficient by the accreditation body; and documentation of completion of the assessments and a statement of proficiency by the accreditation body is available Training a) Each assessor shall satisfactorily complete a training program approved by the accreditation body responsible for on-site assessments. The training program shall include ongoing changes to and/or adoption of applicable regulations, standards, and sampling, and measurement methods and technologies. b) Each accreditation body shall be responsible for ensuring that the training course used to train its assessors meets this Standard. This training program requires assessors to

16 May 1, 2007 page 10 participate in an Assessor Basic Training Course, including attainment of a passing score on the written examination for the course. c) Assessors shall complete Technical Training requirements for at least one technical discipline addressing sampling (grab or composite) or measurement technologies or a combination of technology and method in areas of accreditation, such as, for example: i. air matrices (ambient, indoor and outdoor air, point source and fugitive emissions, soil atmospheres, air and continuous emissions monitoring); i iv. solids, including soil, sediment, sludge and solids monitoring; water, including surface, waste, drinking and groundwater; biological samples including, for example, whole animals, fish, shell, plant or animal tissue and microorganisms. d) Assessors shall complete annual refresher/update training in order to: i. be familiar with the relevant legal regulations, accreditation procedures, and accreditation requirements; have a thorough knowledge of the relevant assessment methods and assessment documents; i be thoroughly familiar with the various forms of records described in Clause 7.6, Document and Record Review; iv. be thoroughly cognizant of data reporting, analysis, and reduction techniques and procedures; v. have a working knowledge and be conversant with specific sampling and measurement techniques or types thereof for which the accreditation is sought and, where relevant, with any associated sampling preservation procedures; and vi. be able to communicate effectively, both orally and in writing. NOTE 1: Technical disciplines may be related to regulatory programs such as the CAA, RCRA, TSCA, SARA, FIFRA, CWA, CERCLA and SDWA. NOTE 2: The assessor training program can be implemented by either an accreditation body, assessor bodies, or other approved entities. NOTE 3: The purpose of technical training is to ensure consistency of knowledge and techniques among the assessors. The technical training assumes a level of basic knowledge of the subject and concentrates on the elements of the sampling and measurement technology or methods that are key to properly assuring FSMO competency to deliver data of known and documented quality Expert Roles and Responsibilities The accreditation body shall identify experts capable of performing specific tasks within assessment teams based on their education, training, technical knowledge, skills and experience. See ISO/IEC 17011:2004(E) Clauses through NOTE 1: Experts perform specific and limited tasks within assessment teams by witnessing FSMO activities within the expert s field of competence and reporting to the lead assessor. See ISO/IEC 17011:2004(E) Clause

17 May 1, 2007 page 11 NOTE 2: Experts have the same ethical responsibilities as all other personnel associated with the accreditation body. See ISO /IEC 17011:2004(E) Clause Monitoring ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause Not withstanding ISO/IEC 17011:2004(E) Clause 6.3.2, each assessor conducting assessments of FSMOs shall be observed on-site at least once in every three years. Supporting evidence (see the referenced ISO clause) is not sufficient in itself to define the continued competence of an assessor. NOTE: The process or system to evaluate assessor performance should be sufficient to demonstrate compliance with this Standard and be consistent with the organization s employee evaluation program. 6.4 Personnel Records ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause h) number of assessments completed; and i) date of most recent updating of record. 7.0 ACCREDITATION PROCESS 7.1 Accreditation Criteria and Information ISO/IEC 17011:2004(E), Clause The criteria for accreditation of FSMOs (conformity assessment bodies) shall be based on ISO/IEC Guide 17011, and relevant modifications for application to Field Sampling and Measurement Organizations as given in this TNI Standard, General Requirements for Accreditation Bodies Accrediting Field Sampling and Measurement Organizations, Volume General Applicability a) Accreditation shall apply to the FSMO (organization) and not to any one individual or group of individuals within an organization. b) Accreditation shall be granted as follows: i. an Umbrella Accreditation: To a parent FSMO operating under a single common Management system (e.g., at a corporate or divisional level), and providing field sampling and measurements across various jurisdictions from multiple non-contiguous fixed-based locations; or an Individual Accreditation: To a single fixed-base FSMO entity or to each noncontiguous entity of a parent FSMO, each with its own management system, providing sampling and measurements across various jurisdictions.

18 May 1, 2007 page 12 c) The accreditation body shall determine whether a FSMO qualifies for an umbrella accreditation or for an individual accreditation, taking into account the presence or absence of a common management system, ownership/management, technical oversight, and scope of accreditation as detailed in the FSMO accreditation application. NOTE 1: FSMO activities, whether from a fixed or mobile base, that encompass multiple field sampling and measurement locations, do not require separate accreditations. NOTE 2: A mobile sampling and measurement unit, operating under the FSMO management system, does not require a separate accreditation ISO/IEC 17011:2004(E), Clause Accreditation Applicability Types of FSMOs and Applicability Accreditation shall apply to those FSMOs engaged in environmental field sampling and/or measurement activities (for example, research, development, monitoring and regulatory compliance) and reporting under federal, state, and local (mandated or not) testing programs, or for other purposes. NOTE: Field sampling and measurement activities may be related to regulatory programs such as the CAA, RCRA, TSCA, SARA, FIFRA, CWA, CERCLA,SDWA and CEM monitoring or may be a result of other provisions or specialty areas promulgated as a result of action by a local, state or federal authority Types of Matrices and Applicability Scope of Accreditation Accreditation shall be granted for Field Sampling by Matrix/Technology, and/or for Field Measurements by Matrix/Technology. NOTE: Accreditation may also be granted for Field Sampling/Measurement Methods, or analyte as specific to regulatory programs The accreditation body shall make publicly available a list of scopes they are competent to assess. Accreditation may be granted by Matrix (either sampling or measurement) such as: a) air matrices (ambient, indoor, outdoor air, point source and fugitive emissions, soil atmospheres, air monitoring, and continuous emissions monitoring); b) solids, including soil, sediment, sludge and solids monitoring; c) water, including surface, waste, drinking and groundwater; and d) biological samples, including, for example, whole animals, fish, shell, animal or plant tissue and microorganisms. NOTE: Accreditation may also granted by Field Sampling/Measurement methods, or analyte/analyte group as specific to those programs defined previously under Types of FSMOs and Types of Matrices. 7.2 Application for Accreditation

19 May 1, 2007 page ISO/IEC 17011:2004(E), Clause Components of Accreditation Initial Application An Accreditation body shall require a FSMO seeking accreditation to complete and submit a formal application package to the accreditation body to include: a) legal name and contact mailing address; b) billing address (if different from a); c) name and address of owner(s) if privately held; d) a scope of accreditation including: i. field sampling and field analytical methodsmeasurement technologies for which accreditation is being requested; i a complete listing of sampling and measurement methods employed including analytes to be; and address(s) of all FSMO entities under the scope of the accreditation, and address(s) of the field sampling and measurement locations, if applicable, for selection of on-site assessment observations.. 1. The accreditation body shall have in place a procedure for mutually selecting and agreeing, with the FSMO, the field sampling and measurement locations and sampling/measurement personnel for observations in accordance with the scope of the requested accreditation. 2. The accreditation body shall have in place a procedure for selecting field sampling and measurement locations that provide a representative sampling of such locations and a representative sampling across field sampling and analytical methods and FSMO locations, such that all activities are assessed within an agreed timeframe not to exceed three accreditation cycles. e) name and contact information of the responsible person(s) and or quality assurance officer, however named; f) normal hours of operation for each FSMO entity included in the Scope; g) a description of the FSMO type (for example, commercial, federal, hospital or health care, state, academic institute, public water system, public wastewater system, industrial/industry with discharge permits, mobile, consulting or engineering firm); h) job description summaries of management and supervisory positions responsible for field sampling and measurement activities, with reporting relationships between positions; i) job description summaries of field sampling and measurement positions, with reporting relationships between positions;

20 May 1, 2007 page 14 NOTE: Documentation of representative individual field sampling and measurement personnel along with their qualifications and any applicable personal certifications will be examined by the accrediting body during on site assessments (see 7.7.3). h) a summary of mobile units, listed by function, that are integral to field sampling and measurement activities and are employed by the FSMO facilities being considered for accreditation; i) a description of the FSMO s proficiency testing program, and copies of the results of the previous three Proficiency Testing proficiency testing samples/programsperformed, if applicable; j) other documents as requested by the accreditation body or approved assessment team. k) Examples of documents that shall be provided include those related to the quality manual and evidence of its application across the FSMO locations. l) Examples of documents that may be requested include representative Standard Operating Procedures, Work Instructions, copies of calibration and maintenance records, field notebooks/records, internal or external quality audits, corrective/preventive action reports, and organization charts, etc. m) Examples of documents that verify the implementation of section of ISO/IEC17025 and the Vol. 1 TNI-FSMO Standard Personnel qualifications/certifications statements a) As part of the application package, the accreditation body shall request from the FSMO a summary table of the qualifications, experiences, training, and any certifications of designated supervisory personnel in their areas of responsibilities, specifically those related to the technical and quality aspects of sampling and measurement activities. b) Educational standards, experience, and training for these designated personnel shall be at the discretion of the FSMO management, but typical of industry standards. The accreditation body and/or assessment team may provide feedback on the adequacy of the designated personnel to carry out their assigned FSMO responsibilities, but shall not deny accreditation status based on perceived inadequacies in this area. c) The accreditation body and/or on-site assessment team shall review the qualifications, training, and experiences of selected FSMO personnel actually engaged in field sampling and measurement as part of assessment activities, including observations of sampling and measurement methods. d) The accreditation body or assessment team shall have the option to request information on or observe staff not originally indicated in the application package if such inclusion is pertinent to the scope of the accreditation or on-site assessment. NOTE: Applicable certifications may include, for example, Registrations or Certifications to professional standards (e.g., registered geologist, Professional Engineer) Accreditation fee The accreditation body shall determine the applicability, frequency, and level of any fees.

21 May 1, 2007 page 15 NOTE: If accreditation is sought from more than one accreditation body, each accreditation body may assess the FSMO an applicable accreditation fee ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause Resources Review (ISO/IEC 17011:2004(E), Clause 7.3) The accreditation body shall document the procedure for conducting an internal audit of its ability to assess a FSMO (CAB) and document the audit results The accreditation body shall initiate processing of completed applications for accreditation in the chronological order that the applications were received. 7.4 Subcontracting the Assessment (ISO/IEC 17011:2004(E), Clause 7.4) 7.5 Preparation for Assessment ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause NOTE: Experts are not eligible to conduct staff interviews, observe, or cite deficiencies in the absence of an assessor ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause Upon request, the accreditation body shall provide the FSMO with all forms and records pertaining to the assessor team member s credentials and qualifications, including certification of freedom from conflicts of interest that may impact the assessors objectivity and impartiality. Such information shall be provided to the FSMO management even if the request is made after the conclusion of the on-site visit The accreditation body shall request the FSMO to provide written consent or objections on the choice of a particular assessor ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause The accreditation body shall have in place a procedure for mutually selecting and agreeing, with the FSMO, the field sampling and measurement locations and sampling/measurement personnel for observations in accordance with the scope of the requested accreditation The accreditation body shall have in place a procedure for selecting field sampling and measurement locations that provide a representative sampling of such locations and a representative sampling across field sampling and analytical methods and FSMO locations, such that all activities are assessed within an agreed timeframe not to exceed three accreditation cycles.

22 May 1, 2007 page ISO/IEC 17011:2004(E), Clause The AB shall provide notice and scope of an announced on-site assessment, for example, by letter, , telephone call, or published schedule, on the agreed date and schedule and shall request the FSMO respond with the acceptance of the proposed time, date and location The on-site assessment shall occur during normal business hours unless prior arrangements have been made or extenuating circumstances intervene. ` ISO/IEC 17011:2004(E), Clause Document and Record Review ISO/IEC 17011:2004(E), Clause Pre-Assessment Documents After receipt of an application, the assessment team shall: a) request in writing any additional information, such as pertinent quality and training records, operating procedures, documents, and methods to be examined, if not part of the application package, necessary for a successful assessment, including a rationale for the request; b) review other relevant accreditation correspondence, status and any pending actions and determine: i. whether site access or security advance planning/notification is required; whether any special site safety procedures may be required of the assessment team Assessment Documents Prior to an announced assessment (for items a) and b)), or at the conclusion of an on-site assessment (for items c) to e)), the lead assessor shall provide the FSMO with: a) notice and scope of an announced on-site assessment, for example, by letter, , telephone call, or published schedule, and the FSMO acceptance of the proposed time, date and location; b) copies of any checklists used to evaluate conformance with this the FSMO Volume I Standard and to document assessment findings, if not already provided by the AB; c) an effectiveness/adequacy appraisal form (for feedback from the FSMO to the assessors on the processes employed); d) an assessment confidentiality notice, allowing the FSMO to: i. claim confidential business information on information/documents gathered during the assessment; and restrict access to requested information/documents for national homeland security reasons; e) opening and closing session attendance sheets;

23 May 1, 2007 page ISO/IEC 17011:2004(E), Clause NOTE: Nonconformities found during document and records review may include inadequate documentation to support the scope of accreditation, a quality manual that does not comply with TNI Standard Volume 1, General Requirements for Field Sampling and Measurement Organizations, absence of evidence of qualified personnel or standard operating procedures for the requested accreditation or absence of applicable PT data (but see Clause , Interim Preliminary Accreditation for an exception to PT sample data). 7.7 On-Site Assessment ISO/IEC 17011:2004(E), Clause ISO/IEC 17011:2004(E), Clause Conducting an On-Site Assessment The lead assessor shall advise the accreditation body as soon as possible if and when an FSMO refuses admittance to the site and shall advise the FSMO that such refusal is grounds for automatic failure to receive accreditation or loss of an existing accreditation, unless extenuating circumstances are accepted by and documented with the accreditation body. a) The opening conference shall include: i. agreement on the scope, purpose, duration and locations (if both fixed-base and field locations are part of the assessment) of the assessment; i iv. the introduction and identification of each assessor along with their qualifications and areas of responsibilities; the identification of the FSMO s processes and personnel to be examined, including those selected for field observations; a discussion of the responsibilities of the FSMO s key managers and field sampling and measurement personnel; v. a discussion concerning procedures related to business confidential information; vi. a review of any safety considerations, necessary for assessor protection while in certain parts of the FSMOs facilities. NOTE 1: The FSMO shall not request the assessors to sign any waiver of responsibility on the part of the FSMO for injuries incurred during an assessment or simply being on the FSMO site. NOTE 2: The Accreditation body should request that the FSMO provide (or pre-advise the assessors of such requirements) any necessary safety gear and instructions for safe use during the site visit. v vi ix. a review of the appropriate accreditation standards for assessment and/or checklists used to judge compliance; an opportunity to raise and discuss any assessment issues or procedures; and the time and place of the closing conference and a review of the post assessment timeline.

24 May 1, 2007 page 18 b) The closing conference shall include: i. a discussion and informal debriefing with the FSMO s representative(s) to provide preliminary findings, potential impacts and their criticality and severity, and the deficiencies and their relationship to the accreditation standards; i iv. a discussion of the process whereby the accreditation body makes the final determination of the assessment based upon reported findings which may include additional findings not discussed in the closing conference; a discussion of any deficiencies which may be the subject of additional actions, such as FSMO improper or potentially illegal activities; a discussion of any contested assessor findings which, if not resolved during the closing conference, shall be identified and included in the preliminary report to the accreditation body for final resolution on the validity of the contested finding; and v. informing the FSMO that a final assessment report will be issued within thirty (30) days, encompassing all relevant information concerning the FSMO s accreditation status and conformance with these Standardsthe FSMO Volume I Standard. NOTE: The on-site assessor may use a variety of tools in the assessment process including prior experiences of the assessor, his/her observations or interviews with the FSMO staff, examination of SOPs, raw data, and the FSMO s documentation and records ISO/IEC 17011:2004(E), Clause Staff Interviews and Observations Any deficiencies in the interviews or observations shall be discussed with the effected affected staff and summarized during the closing conference. The assessment team shall conduct staff interviews and/or observations: a) to the extent necessary, and if appropriate, for determining compliance with these Standardsthe FSMO Volume I Standard, either at the FSMO s fixed base, field location(s) or a combination of both; and b) with a selected cross section to judge FSMO and staff competency across the scope of the accreditation, including, for example, sampling and measurement activities and procedures, calculations, data reductions, transfers and reporting, data verification and validation, calibrations, quality control and assurance practices, and adherence to standard operating procedures, standard methods and the FSMO quality manual. NOTE 1: The assessment team may request selected sampling and measurement personnel conduct or describe in detail a sampling or measurement event, to demonstrate knowledge of, for example, the procedure or method and equipment used, QA/QC procedures, and calibrations. NOTE 2: Performance Evaluation sample(s)proficiency Testing Sample(s), or Certified Standard(s), if available, may be used to physically demonstrate competence competency for the selected scope of accreditation for matrix/technology/analyte.. NOTE 3: The accreditation of a particular FSMO depends primarily upon the assessment team s findings, and much of the on-site assessment depends upon the assessor's observations of existing conditions. See ISO/IEC 17011:2004(E), Clause 3.21, Witnessing: Observation

25 May 1, 2007 page 19 of the CAB carrying out conformity assessment services within its scope of accreditation (i.e., observing operations and processes).